Location: Pune, India (Remote Flexibility Available)
Job Type: 1-Year Fixed-Term Contract
Department: PV Medical Group
Company: PrimeVigilance
Experience Required: Minimum 2–6 years in Pharmacovigilance (Freshers Not Eligible)
About the Company
PrimeVigilance, part of the Ergomed Group, is a globally established pharmacovigilance and medical services organization. Since its inception in 2008, the company has demonstrated consistent international growth, supporting pharmaceutical, biotechnology, and medical device clients across Europe, North America, and Asia.
With expertise spanning Pharmacovigilance, Medical Information, Regulatory Affairs, and Quality Assurance, PrimeVigilance delivers high-quality, compliant safety solutions across all therapeutic areas.
Job Overview
The PV Physician I / II will be responsible for medical review, evaluation, and risk assessment of safety data, including Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs). This role requires strong expertise in pharmacovigilance processes, signal detection, and aggregate reporting, along with advanced proficiency in both English and Japanese.
Key Responsibilities
Medical Review and Case Processing
Perform medical and causality assessment of post-marketing ICSRs and clinical trial SAE reports
Evaluate seriousness, expectedness, listedness, and company causality
Review coding accuracy and ensure data quality in safety databases
Provide medical comments and follow-up queries where required
Regulatory and Safety Oversight
Act as Qualified Person for Pharmacovigilance (QPPV) or support QPPV activities
Contribute to Periodic Safety Update Reports (PSUR/PBRER) and Development Safety Update Reports (DSUR)
Review scientific literature for safety signals and case identification
Support responses to global regulatory authority queries
Signal Detection and Risk Management
Participate in signal detection activities, including data review and signal validation
Evaluate and categorize potential safety signals and recommend risk mitigation strategies
Contribute to benefit-risk assessment reports and Risk Management Plans (RMPs)
Review line listings and support safety review meetings
Required Qualifications
Medical degree (MBBS or equivalent) is mandatory
2–6 years of hands-on experience in Pharmacovigilance or Drug Safety
Strong expertise in ICSR review, aggregate reporting (PBRER, DSUR), and signal detection
Proficiency in English and Japanese (spoken and written – mandatory)
Advanced knowledge of global pharmacovigilance regulations and ICH guidelines
Strong analytical, communication, and presentation skills
Ability to manage multiple projects in a cross-functional, global environment
Proficiency in MS Office tools
Why Join PrimeVigilance
Global exposure across diverse pharmacovigilance projects and therapeutic areas
Structured training programs and continuous professional development
Inclusive, employee-centric workplace culture
Strong emphasis on work-life balance and employee well-being
Opportunity to collaborate with international teams in a dynamic environment
Important Note for Applicants
This is a specialized pharmacovigilance physician role requiring prior industry experience and medical qualification. Freshers are advised to begin with entry-level roles such as Drug Safety Associate or Pharmacovigilance Associate before progressing to physician-level positions.
How to Apply
Apply through the official company careers page or trusted global job platforms. For more verified pharmacovigilance and clinical research jobs, visit ThePharmaDaily.com
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Witney |Ontario :
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Montreal |Brussels :
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Brazil | Sao paulo |Attica :
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